Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Abbott

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Biological: adalimumab

Biological: placebo

Study type

Interventional

Funder types

Industry

Identifiers

M03-600

Details and patient eligibility

About

To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

Enrollment

226 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/Females at least 20 years of age.
Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
Females have a negative pregnancy test at screening.
Diagnosis of RA and met ACR criteria.
Must discontinue any TNF at least 2 months prior to baseline.
In condition of general good health.

Exclusion criteria

History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
History of current acute inflammatory joint disease.
Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
Recent (3 month) history of influenza or pneumococcal bacterial infection.
Known positive human immunodeficiency virus (HIV) status.
Positive hepatitis B or hepatitis C virus.
Positive PPD >5 mm.
Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.